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510(k) Data Aggregation
(227 days)
· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.
The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
The REDAPT Anteverted Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the REDAPT Anteverted Cemented Liner, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit, quantitative acceptance criteria for novel performance. However, it does mention various mechanical tests and their successful completion, which imply meeting internal or industry-standard acceptance criteria.
| Acceptance Criterion (Implicit/General) | Reported Device Performance (as stated or implied) |
|---|---|
| Withstanding expected in vivo loading | "A review of the mechanical data indicates that the REDAPT Anteverted Liners are capable of withstanding expected in vivo loading without failure." (Page 4) |
| Fatigue performance | Performed, implied success for substantial equivalence. (Page 4) |
| Push out, Lever Out, Torque-to-Failure | Performed, implied success for substantial equivalence. (Page 4) |
| Range of Motion | Performed, implied success for substantial equivalence. (Page 4) |
| Impingement | Performed, implied success for substantial equivalence. (Page 4) |
| Wear performance | "Wear performance of the cross-linked polyethylene liners are substantially equivalent to the REDAPT 0-Degree Liners in K150790 and the REFLECTION Liners in K002747." (Page 4) |
| Sterility/Endotoxin | "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance..." (Page 4) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for the mechanical tests. For medical devices like hip liners, samples often refer to the number of devices tested. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are in vitro mechanical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through objective engineering standards and mechanical testing, not expert clinical consensus or interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints. Mechanical tests have pass/fail criteria based on engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a hip implant, not an AI diagnostic device. An MRMC study is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. Its performance is assessed through its physical properties and mechanical behavior.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through established engineering principles, material specifications (e.g., ASTM F648 for highly cross-linked polyethylene), and industry-standard mechanical testing protocols. These tests simulate in vivo conditions to assess properties like fatigue, push-out strength, lever-out resistance, torque-to-failure, range of motion, impingement, and wear. The success criteria are typically defined by these standards or comparative data from predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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(236 days)
The REDAPT Porous Acetabular Shell and Cemented Liner are indicated for:
. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
The REDAPT Porous Acetabular Shell designed for cementless use is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.
This document is a 510(k) summary for the REDAPT Porous Acetabular Shell and Cemented Liner, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a traditional study with acceptance criteria and a detailed analysis of performance metrics in clinical trials.
Therefore, the requested information categories (#1-7 for a study and its acceptance criteria, and specific details for #8-9 for training sets) are generally not applicable in the context of this medical device submission. The FDA 510(k) process for devices like this typically relies on bench testing, material characterization, and comparisons to predicate devices to establish substantial equivalence, rather than extensive human clinical trials or AI performance evaluations.
However, I can extract the information provided that is relevant to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for a study with reported device performance in the way one might expect for a clinical trial or AI performance evaluation. Instead, it lists various tests performed to establish substantial equivalence. The "performance" is implied by the successful completion of these tests and the determination of substantial equivalence to predicate devices, meaning the device performed comparably or met established standards for the indicated tests.
The listed tests are:
| Test Type | Performance Claim / Outcome |
|---|---|
| Porous structure characterization | Details discussed in Porous Structure Master File MAF – 2596. Includes: Composition, Trace element, Microstructure, Strut shape and size, Surface pore diameter, Mean void intercept length, Porosity, Shear mechanical properties, Tensile mechanical properties, Bending mechanical properties, Compressive mechanical properties, Abrasion resistance. |
| Implied Outcome: Met established specifications for each. | |
| Construct fatigue testing | A review of the mechanical data indicates that the REDAPT Porous Acetabular Shell and Cemented Liner are capable of withstanding expected in vivo loading without failure. |
| Implied Outcome: Met fatigue endurance requirements. | |
| Acetabular screw testing | Implied Outcome: Met mechanical requirements for screw fixation. |
| Cemented liner testing | Implied Outcome: Met mechanical requirements specific to cemented liners. |
| Biocompatibility | Implied Outcome: Biocompatible according to relevant standards. |
| Range of Motion | Implied Outcome: Achieved acceptable range of motion without impingement. |
| Impaction | Implied Outcome: Demonstrated acceptable impaction characteristics. |
| Wear performance | Addressed based on a comparison of the minimum thickness in the rim and load bearing regions of the liners with the predicate devices. |
| Implied Outcome: Wear performance is comparable to predicate devices. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each test. For mechanical and material tests of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., 5-10 samples per test group). The document does not provide these details.
- Data Provenance: Not specified. Standard practice for such tests would be laboratory testing conducted by the manufacturer or a contracted testing facility in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a submission for a physical medical device (hip implant components), not for an interpretative AI/imaging device. "Ground truth" in this context would refer to the validated material properties, mechanical performance under specified loads, and biocompatibility, which are established through standardized laboratory testing protocols, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical hip implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation relies on:
- Physical and Chemical Material Standards: Adherence to established ASTM (e.g., ASTM F648 for cross-linked polyethylene) and ISO standards for materials like titanium alloy and polyethylene.
- Mechanical Test Standards: Compliance with relevant mechanical testing standards (e.g., for fatigue, screw fixation, wear simulation) that simulate in vivo conditions.
- Biocompatibility Standards: Compliance with ISO 10993 series or similar standards for biological evaluation of medical devices.
- Comparison to Predicate Devices: Performance characteristics (e.g., wear, mechanical strength) found to be substantially equivalent to those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no AI component or "training set" in the context of this device's submission.
9. How the ground truth for the training set was established
Not applicable.
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(78 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.
The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:
The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.
Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:
- Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
- Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
- Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.
The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.
Given this context, here's the information extracted from the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance | "A review of the mechanical testing results indicated that the Smith & Nephew Oxinium DH femoral heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." |
| Indications for Use | The stated Indications for Use are identical to the predicate devices, covering rehabilitation of hips damaged by trauma, inflammatory/degenerative joint disease, avascular necrosis, fractures, etc. |
| Design & Materials | "The Smith & Nephew Oxinium DH femoral heads are similar in overall design, indications, and materials to the Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners." |
| Biocompatibility | (Not explicitly detailed in the provided text, but implied through substantial equivalence to predicate devices likely already deemed biocompatible.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
- Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
- Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth Type:
- For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
- For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.
In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.
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(198 days)
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
- Patients suffering from disability due to previous fusion
- Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.
The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.
The provided text describes the "Excia Total Hip System" and its clearance through the 510(k) premarket notification process by the FDA. This specific document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting de novo clinical study data to prove novel acceptance criteria.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance directly.
- Sample sizes used for a test set or its data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.) for this particular device's testing (as it relies on equivalence).
- Sample size for a training set or how its ground truth was established, because it is comparing to previously approved predicate devices, not training an AI algorithm.
Instead, the provided text indicates that the device met acceptance criteria by demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing.
Here's an overview of how the "acceptance criteria" are addressed in the context of this 510(k) submission:
Acceptance Criteria and Device Performance (Demonstrated by Substantial Equivalence):
The acceptance criteria for the Excia Total Hip System are implicitly that it performs as safely and effectively as its predicate devices, as demonstrated by meeting relevant industry standards and guidance documents for orthopedic implants.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance and Durability (e.g., fatigue, wear, strength, fixation) in accordance with relevant standards. | All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were executed. Additionally, testing adhered to specific guidance documents for: |
- Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
- Metallic Plasma Sprayed Coatings on Orthopedic Implants
- "Mechanically Locked" Modular Implant Components
- Acetabular Cup Prostheses
- Femoral Stem Prostheses
- Ceramic Ball Hip Systems
- Ultrahigh Molecular Weight Polyethylene (UHMWPE)
These tests confirmed the device's mechanical integrity and performance characteristics are comparable to or meet the requirements established for substantially equivalent predicate devices. |
| Biocompatibility (Material safety) | Implied by the use of standard materials like CoCr, Ti, Ti plasma spray, UHMWPE, and PMMA, which are well-established in orthopedic implants and have documented biocompatibility. No specific new testing is detailed, but adherence to guidance documents suggests material safety was considered. |
| Clinical Indications for Use (Safety and Effectiveness for specific patient populations) | The indicated uses for the Excia Hip System (rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, etc.) are consistent with those of the predicate devices. The FDA's 510(k) clearance confirms substantial equivalence for these indications. |
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation and a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with human subjects.
- Sample Size Used for Test Set and Data Provenance: Not applicable in the context of this 510(k) summary, as it describes non-clinical testing against established standards and comparison to predicate devices, not a clinical test set from human data. The "test set" would consist of the device components themselves undergoing specified mechanical and material tests.
- Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. Ground truth is established by engineering standards, material science, and the documented performance of predicate devices.
- Adjudication Method: Not applicable. Performance is measured against predetermined physical properties and regulatory standards.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a medical device (hip replacement system), not an AI algorithm requiring MRMC studies.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
- Type of Ground Truth Used: The ground truth is rooted in established engineering standards, material specifications, and the historical performance and regulatory clearance of the predicate devices. This includes mechanical properties, material composition, wear rates, and fixation attributes, as defined by the various guidance documents listed.
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
- How Ground Truth for Training Set was Established: Not applicable.
Summary of the Substantial Equivalence Claim:
Aesculap believes the Excia Total Hip System is substantially equivalent in design and performance to the following predicate devices:
- BiCONTACT Hip System (K040191)
- 36mm V40 Femoral Head Components (K022077)
- Alloclassic Zweymueller (K030373)
- SC Total Hip System (K031474)
- Smith & Nephew Hip System (K022902)
- Pinnacle Duofix HA Acetabular Cup (K031495)
- Trident Porous Ti Acetabular Component with Coating (K013475)
The FDA's clearance (K042344) indicates their agreement that the Excia Total Hip System is substantially equivalent to these predicate devices for its intended use. This substantial equivalence determination is the primary "proof" that the device meets the necessary safety and effectiveness criteria for market entry under the 510(k) pathway.
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